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A new study shows that GLP-1 injectables, including Ozempic, Wegovy and Saxenda, could cause severe digestive complications.
A new study suggests that people taking popular injectable weight loss medications, including Wegovy and Ozempic, may be susceptible to serious complications.
In a research letter published in the Journal of the American Medical Association (JAMA), University of British Columbia researchers noted that the individuals may be more likely to develop severe digestive problems such as stomach paralysis, pancreatitis, and bowel obstructions than those who take other weight loss medications, CNN reported.
The researchers’ findings were obtained by filtering through a random sample of more than 16 million insurance claims from a broad prescription drug database filed between 2006 and 2020.
While the probability of the complications occurring in individuals appeared to be low, researchers contend that demand for the medications has skyrocketed, with tens of millions using them globally.
They added that even uncommon risks could result in hundreds of thousands of additional cases.
“When you have millions of people using these drugs, you know, a 1% risk still translates to many people who may experience these events,” said lead study author Dr. Mahyar Etminan, an epidemiologist at the University of British Columbia.
Researchers looked for patients who received two injectable medications, semaglutide (injected weekly) and liraglutide (a daily injectable). The medicines are GLP-1 agonists, which delay the transit of food through the stomach.
They can help people with diabetes regulate their blood sugar and lead to significant weight loss for those with or without diabetes.
The U.S. Food and Drug Administration authorized semaglutide in 2021 for obese patients who do not have diabetes and need to lose weight. It is marketed as Ozempic when it is recommended for diabetes and Wegovy when used for weight reduction.
The prescribing information for Wegovy warns about several serious side effects, including pancreatic inflammation, gallbladder and kidney problems, blocked intestines, severe allergic reactions, increased heart rate, suicidal thoughts and vision changes in people with diabetes.
A warning for ileus, or obstructed intestines, was also recently added to Ozempic’s warning label. According to the labeling, the most prevalent adverse effects include nausea, vomiting and constipation.
In absolute terms, the group receiving Ozempic had a nearly 1% rate of new occurrences of stomach paralysis. Researchers discovered no bowel blockages in the Ozempic group, and there was a 0.5% risk of pancreatitis.
There were four incidences of gastroparesis or stomach paralysis among the 600 patients using Ozempic, two cases of pancreatitis, no bowel blockages, and five instances of biliary illness.
The research thus far has limitations, including that it is observational and can’t prove the drugs caused the diagnosed conditions. Additionally, though the researchers only studied semaglutide and liraglutide, they surmise complications may be linked to all GLP-1 class medications. This class includes tirzepatide, currently marketed as the diabetes medication Mounjaro and under review by the FDA for weight loss, reports Time magazine.
While researchers took steps to try to find individuals who might have been using the drugs for weight loss, there is no sure way to confirm why they were injecting them.
Still, this is the first time researchers have been able to put numbers to these risks. Experts who were not involved in the study said it was well conducted but has some limits and won’t be the final word.
Researchers hope their study will help people make more informed drug decisions and that regulatory agencies and drug makers will consider updating their products’ warning labels, which currently don’t include the danger of gastroparesis. Time reports that on Sept. 28, the U.S. Food and Drug Administration (FDA) “asked manufacturers of semaglutide drugs to include a warning in the medication label about the possible risk of intestinal blockage, after receiving 8,500 reports of the condition from both diabetic and non-diabetic users.”
Ozempic manufacturer Novo Nordisk said it stands behind the safety and effectiveness of all its GLP-1 medications when used correctly.
“With respect to the study, as the authors acknowledge, the study has limitations, including potential confounding by indication and by other factors,” the company said, CNN reported.
The manufacturer recommended patients take their medications for their approved indications, adding, “Treatment decisions should be made together with a healthcare provider who can evaluate the appropriateness of using a GLP-1 based on assessment of a patient’s individual medical profile.”
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